Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression

NCT ID: NCT00186485

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2010-07-31

Brief Summary

We hope to learn whether this stimulation of neurons in the front part of the brain may relieve depression.

Detailed Description

The primary objective of this study is to examine the safety and efficacy of rTMS in the management of treatment-resistant bipolar depression.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Right Sided Low Frequency Unilateral TMS

1Hz unilateral TMS delivered to the right DLPFC using the MagStim device

Group Type: EXPERIMENTAL

MagStim

Intervention Type: DEVICE

The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain

Interventions

MagStim

The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• DSM IV Bipolar I or II Disorder with current major depressive episode
• Prior failure to respond to or tolerate at least 2 adequate pharmacotherapy trials
• Ham-D score greater than or equal to 18

Exclusion Criteria

e. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes; f. A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire (see Attachment H) g. Lifetime treatment with more than 12 antidepressant medication trials, at any dose or duration, either monotherapy or combination therapy from the list summarized in Attachment I. h. ECT treatment within 3 months prior to the screening visit; i. Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous j. History of treatment with rTMS therapy for any disorder; k. History of treatment with Vagus Nerve Stimulation; l. Use of any investigational drug within 4 weeks of the randomization visit; m. Use of fluoxetine within 6 weeks of the randomization visit; n. Use of an MAOI within 2 weeks of the randomization visit; o. Use of any medication(s) listed on the Excluded Medication List (Attachment J) within 1 week of the randomization visit; p. Significant acute suicide risk, defined as follows: Suicide attempt within the previous 6 months that required medical treatment; or >2 suicide attempts in the past 12 months; or Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator#s opinion, is likely to attempt suicide within the next 6 months. q. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; r. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;s. Known or suspected pregnancy; t. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial; u. Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to randomization); v. Clinically significant laboratory abnormality, in the opinion of the investigator; w. Women who are breast-feeding; x. Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Hugh Brent Solvason

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hugh Brent Solvason

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

Stanford 79133

Identifier Type: -

Identifier Source: org_study_id